Clinical trial · Interventional
Evaluation of NiTi Laparoscopic Compression Anastomosis Clip (LapCAC) Device for Intra-Corporeal Lap-Colectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study involves adult subject requiring colonic anastomosis following laparoscopic intra-corporeal surgery. The anastomosis will be performed by using nitinilclip by the LapCAC device instead of staplers. Endpoints: safety-Functioning secured anastomosis and no occurrence of adverse event related to device use. The efficacy endpoint of this study includes clinical evaluation of characteristic parameters related to intestinal surgeries. Discharge day (or ready-for-discharge) Proven anastomotic leak rate (clinically or radiological) Stenosis / stricture at anastomosis Patient recovery level will be assessed every day during hospitalization and in the follow up visits.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LapCAC Laparoscopic Compression Anastomosis Clip | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Functioning anastomosis without leaks or obstructions
Secondary outcomes (1)
- measure
- Functioning anastomosis without stenosis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient age over 18 years. 2. Patient schedule for colonic surgery which requires a bowel anastomosis (right colon, left colon, sigma). 3. Patient is able to understand and to sign the Informed Consent Form. Exclusion Criteria: 1. Patient has known allergy to nickel. 2. Emergency procedure, i.e. patients with bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischaemic bowel, carcinomatosis. 3. Patients with Crohn's disease needed more than one anastomosis. 4. Patient underwent previous major abdominal surgery. 5. Patients under steroid treatment. 6. Patient albumin level less than 3 g/dl 7. Patients under immuno-suppression or cytotoxic treatment. 8. Patients who are participating in another trial which may affect the outcomes data on this study. 9. Patients with contraindications to general anaesthesia. 10. Patients who refuse consent.
References
Publications (0)
Data not yet available